Department of Biometrics, Institute of Neurological Sciences - IFNAP, Nürnberg, Germany.
Interdisciplinary Pain and Palliative Care Center Goeppingen, Schmerz- und Palliativzentrum Göppingen, Göppingen, Germany.
Curr Med Res Opin. 2022 Jul;38(7):1203-1217. doi: 10.1080/03007995.2022.2077579. Epub 2022 Jun 1.
To evaluate efficacy and tolerability of the nonbenzodiazepine antispasmodic pridinol (PRI), as an add-on treatment in patients with muscle-related pain (MRP).
Exploratory retrospective analysis of depersonalized routine data provided by the German Pain e-Registry (GPeR) focusing on pain intensity, pain-related disabilities in daily life, wellbeing, and drug-related adverse events (DRAEs).Primary endpoint based on a global response composite of (a) a clinically relevant analgesic response (relative improvement ≥50% and/or absolute improvement ≥ the minimal clinical important difference) for pain intensity and disability in combination with (b) an improvement in wellbeing (all at end of treatment vs. baseline), and (c) lack of any DRAEs.
Between 1 January 2018 and 31 December 2020, the GPeR collected information on 121,803 pain patients of whom 1133 (0.9%; 54.5% female, mean ± SD age: 53.9 ± 11.8 years) received add-on PRI for the treatment of (mostly acute) MRP originating predominantly in the (lower) back (43.2%), lower limb (26.4%), or should/neck (21.1%). Average daily dose was 7.8 ± 1.8 (median 9, range 1.5-13.5) mg, duration of treatment 12.0 ± 10.2 (median 7, range 3-63) days. In total, 666 patients (58.8%) reported a complete, 395 (34.9%) a partial, and 72 (6.4%) patients no response - either because of lack of efficacy ( = 2, 0.2%) or DRAEs ( = 70, 6.2%). In response to PRI, 41.7% of patients documented a reduction of at least one other pain medication and 30.8% even the complete cessation of any other pharmacological pain treatments.
Based on this real-world data of the German Pain e-Registry, add-on treatment with PRI in patients with acute MRP under real-world conditions in daily life was well tolerated and associated with an improvement of pain intensity, pain-related disabilities, and overall wellbeing.
评估非苯二氮䓬类解痉药匹哚诺尔（PRI）作为附加治疗药物在肌肉相关疼痛（MRP）患者中的疗效和耐受性。
对德国疼痛电子注册中心（GPeR）提供的去识别化常规数据进行探索性回顾性分析，重点关注疼痛强度、日常生活中与疼痛相关的残疾、幸福感以及药物相关不良反应（DRAEs）。主要终点基于（a）疼痛强度和残疾的临床相关镇痛反应（相对改善≥50%和/或绝对改善≥最小临床重要差异）以及（b）幸福感改善的综合（均在治疗结束时与基线相比）的综合（c）无任何 DRAEs。
在 2018 年 1 月 1 日至 2020 年 12 月 31 日期间，GPeR 收集了 121803 名疼痛患者的信息，其中 1133 名（0.9%；女性占 54.5%，平均年龄±标准差：53.9±11.8 岁）接受了 PRI 作为（主要为急性）MRP 的附加治疗，MRP 主要源自（下）背部（43.2%）、下肢（26.4%）或肩/颈部（21.1%）。平均日剂量为 7.8±1.8（中位数 9，范围 1.5-13.5）mg，治疗持续时间为 12.0±10.2（中位数 7，范围 3-63）天。总共有 666 名患者（58.8%）报告完全缓解，395 名（34.9%）部分缓解，72 名（6.4%）患者无反应-要么是因为缺乏疗效（ = 2，0.2%）要么是因为 DRAEs（ = 70，6.2%）。在接受 PRI 治疗后，41.7%的患者记录至少减少了一种其他疼痛药物，30.8%的患者甚至完全停止了任何其他药理学疼痛治疗。
基于德国疼痛电子注册中心的真实世界数据，在日常生活的真实世界条件下，急性 MRP 患者使用 PRI 作为附加治疗药物具有良好的耐受性，并能改善疼痛强度、与疼痛相关的残疾和整体幸福感。
